MasimoSET LNCS Newborn SpO2 Infant/Pediatric Pulse Oximeter Adhesive Sensor


Product Overview

MasimoSET LNCS Newborn SpO2 Infant/Pediatric Pulse Oximeter Adhesive Sensor
MasimoSETĀ® LNCSĀ® Newborn SpO2 Infant/Pediatric Pulse Oximeter Adhesive Sensor - 2413


Device Description

A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 5.00
  • Handling Environment Temperature - Degrees Celsius
    • 70.00
    • -40.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 5.00
  • Storage Environment Temperature - Degrees Celsius
    • 70.00
    • -40.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DQA

    Device Name: Oximeter

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: AN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 870.2700

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 10843997002384

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Device Id: 00843997002387

    Device Type: Unit of Use

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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